Elitone Device

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 11, 2019 Elidah, Inc. Gloria Kolb CEO 810 Main St., Ste C Monroe, CT 06468 Re: K183585 > Trade/Device Name: ELITONE Device Regulation Number: 21 CFR§ 876.5330 Regulation Name: Transcutaneous Electrical Continence Device Regulatory Class: II Product Code: QAJ Dated: December 20, 2018 Received: December 21, 2018 Dear Gloria Kolb: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. {1}------------------------------------------------ You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Angel A. Solergarcia -S for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K183585 Device Name ELITONE Device Indications for Use (Describe) ELITONE is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary | Sponsor: | Elidah, Inc. | |-------------------|------------------------------------------------------------------| | | 810 Main St, Suite C. | | | Monroe, CT 06468 | | | Contact: Gloria Kolb | | | Phone: 978-435-4324 | | | Date Prepared: February 11, 2019 | | Device Name: | Trade Name: Elitone Device | | | Common Name: Non-implanted electrical continence device | | | Classification Name: Transcutaneous Electrical Continence Device | | | Classification Product Code: QAJ | | | Regulation Number: 876.5330 | | | Classification: Class II | | Predicate Device: | Innovo (DEN170049), manufactured by Bio-Medical Research Ltd. | #### Device Description: The Elitone Device provides electrical muscle stimulation (commonly called EMS or E-stim) to treat stress urinary incontinence. Stimulation is delivered to the pelvic floor muscles and surrounding structures through a disposable cutaneous electrode applied to the perineal region. One end of the thin, flexible electrode is positioned proximate the pubis and the other end is positioned proximate the ischial tuberosity. Mildly adhesive and electrically conductive hydrogel portions of each electrode attach the electrode to the perineal tissues and allow comfortable transfer of electrical stimulation through the pelvic floor. The stimulation is controlled by a battery powered, wearable control unit. The housing of the control unit is approximately 55mm x 45mm x 10mm and made of ABS plastic. It includes two pushbuttons that allow the user to increment the voltage (i.e. intensity), and to start, pause and stop device operation. The stimulation utilizes a symmetric, amplitude modulated (2000Hz), sinusoidal waveform. The output intensity operates over a range of levels (0-35) that approximately correspond to a 0-30mA RMS current. The stimulation frequency alternates between a higher frequency portion (50Hz) and a lower frequency portion (10Hz). Higher frequency stimulation is typically used to encourage muscle contraction and strengthening of the pelvic floor muscles. Lower frequency stimulation is typically used to calm detrusor muscle activity, decreasing symptoms of urgency type incontinence. Each treatment session lasts 20 minutes, after which the device turns off automatically. Women are recommended to use the device 3-5 times per week. #### Intended Use: ELITONE is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues. #### Comparison to the Predicate Device: The table below provides comparisons of the Elitone Device to the predicate Innovo device. The primary difference is the application site of the electrical stimulation. The Elitone Device delivers stimulation via {4}------------------------------------------------ a cutaneous electrode placed on the perineal tissues whereas the predicate delivers stimulation via cutaneous electrodes placed on the buttocks and thighs. This technological difference does not raise different questions of safety or efficacy. Further, acceptable methods exist to characterize the technological differences and results from those methods demonstrated substantial equivalence of the Elitone Device. | Technological | Elitone Device | Innovo Device | Comparison and Impact | |---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Characteristic | (New Device) | (DEN170049) | on Safety/Performance | | Indication for Use | Non-implanted muscle<br>stimulator designed to treat<br>stress urinary incontinence<br>in women. It applies<br>stimulation to the pelvic floor<br>muscles and surrounding<br>tissues. | Transcutaneous electrical<br>stimulator indicated for the<br>treatment of stress urinary<br>incontinence in adult females. | Substantially equivalent:<br>Both refer to SUI in<br>women. | | Therapeutic modality | Electrical muscle stimulation | Electrical muscle stimulation | Identical | | Rx or OTC | Rx and OTC | Rx | Suitability for OTC use<br>verified by Usability<br>Testing (see below). | | Targeted tissue | Pelvic floor muscles and<br>surrounding structures | Pelvic floor muscles and<br>surrounding structures | Identical | | Anatomic site of<br>stimulation application | Perineal region | Buttocks and thighs | Different technological<br>characteristics. See notes<br>above. | | Number of output<br>modes | 1 | 1 | Identical | | Number of output<br>channels | 1 | 2 | Substantially equivalent:<br>Both perceived as single<br>channel to user. | | Controls | 2 buttons provide all<br>functionality | 7 buttons provide all<br>functionality | Substantially equivalent:<br>Both interfaces provide<br>simple, intuitive controls. | | Compliance with<br>voluntary standards | IEC 60601-1<br>IEC 60601-2-10<br>IEC 60606-1-2 | IEC 60601-1<br>IEC 60601-2-10<br>IEC 60606-1-2 | Identical | ### Testing Summary: The following performance testing was provided in support a substantial equivalence determination. The Elitone Device passed all testing. - Software Verification and Validation Testing The software for the device was considered to be a ● "moderate" level of concern. Verification and validation testing was completed as recommended by FDA guidance pertaining to medical device software. - . Electrical Safety and Electromagnetic Compatibility (EMC) Testing – Testing was completed by external labs per IEC 60601-1 and IEC 60601-2-10 standards for safety and IEC 60601-1-2 standard for EMC. {5}------------------------------------------------ - Other Performance Testing - Performance of the electrode component was assessed by measuring its impedance, its adhesiveness and its current dispersion. Comparisons were made to legally marketed EMS electrodes. - Biocompatibility Assessment – A biocompatibility evaluation was completed in accordance with the ISO 10993-1 standard. The electrode is considered tissue contacting for a duration of less than 24 hours. The materials, manufacturing processes and use application are the same as those of legally marketed electrodes. Accordingly, no new biocompatibility testing was needed to demonstrate safety and efficacy. - . Clinical Literature Evaluation – A literature review was conducted to demonstrate the safety and efficacy of perineal-applied EMS in the treatment of female urinary incontinence. Articles were reviewed to assess their relevance to the performance and safety of the Elitone device. - . Clinical Testing – Results from a 20 subject study were submitted. Subjects were with mild-moderate predominant stress incontinence who self-administered treatment with Elitone for 6-weeks. Key findings includes clinically significant improvements in incontinence episodes, pad usage and quality of life measures. There were no adverse events that resulted in injury or required medical treatment. - . Usability Testing – 15 subjects participated in a human factors / usability study to assess the device's suitability for safe over-the-counter use. Key finds included: (1) participants with diversity in age, education and familiarity with incontinence were able to self-select as appropriate users of the Elitone device based on the package label, (2) participants were able to understand the instructions for use and a qualified healthcare professional (observer) verified that they correctly self-identified as candidates based on the indications for use and contraindications, and (3) participants were able to apply treatment safely and correctly. #### Risk Management Summary: The Elitone Device has been designed according to Elidah's internal procedures with traceability between the design inputs, design outputs, verification and validation activities. The Elitone Device has been evaluated for risks according to Elidah's internal procedures based on ISO 14971. The risks associated with the Elitone Device were individually and collectively assessed, and the risk/benefit analysis was acceptable. #### Conclusion: The non-clinical data support the safety of the device, and the software verification and validation demonstrates that Elitone performs as intended in the specified use conditions. The clinical literature evaluation, as well as the technological comparison to the predicate device, supports the use of transcutaneous electrical stimulation as an effective treatment of stress urinary incontinence in women. The clinical study supports the effectiveness of the device and confirms the low-risk nature of EMS devices. The usability study was designed to ensure that potential users could self-identify as having stress urinary incontinence (allowing for the use of the product) while also self-identify as not having urge urinary incontinence (excluding them from use). The verbiage used in the product labeling was found to be appropriate for this kind of self-identification in a general population of women. The data included within this submission supports Elitone as a safe and OTC treatment for stress urinary incontinence in women.